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Effect of One Session of Aerobic Exercise and Anodal Stimulation of Dorsolateral Prefrontal Cortex under Hypoxic Condition on Food Craving and Some of its Related Pyschological Factors in Overweight and Obses Men

Protocol summary

Study aim
Determining the Effect of One Session of Aerobic Exercise and Anodal Stimulation of Dorsolateral Prefrontal Cortex under Hypoxic Condition on Food Craving and Some of its Related Pyschological Factors in Overweight and Obses Men
Design
Clinical trial, within-group, counterbalanced, control group, crossover, double-blind on 20 patients. Randomization.com website will be used for randomization.
Settings and conduct
This study will be conducted at Razi University of Kermanshah. Each subject will be exposed to 2 different conditions of electrical brain stimulation in a random order and then will perform a 30-minute endurance exercise session on an ergometer bike.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range 18 to 50 years; resident of Kermanshah city center; body mass index (BMI) 25 to 34.9 kg/m2; having food cravings (scoring a total score of 108 or higher on the 15-item food craving questionnaire and the 12-item visual analog food craving questionnaire); obtaining a certificate of non-restriction from a physician to participate in an exercise program. Exclusion criteria: history of seizures, epilepsy, or other types of neurological diseases; presence of implantable devices or pacemakers in the body; smoking, alcohol, and drug use; presence of musculoskeletal abnormalities or disorders; participation in weight loss programs in the past 6 months; participation in a regular exercise program in the past 6 months.
Intervention groups
In this study, subjects will be exposed to two brain stimulation conditions: 1) anodal stimulation (intervention group) and 2) sham stimulation or placebo effect (control group) in the DLPFC region. The stimulation duration will be 20 minutes and its intensity will be 2 mA.
Main outcome variables
Changes of food craving, impulsivity, risk-taking decision-making, food oreference, appetite, and cognitive flexibility

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241213064044N1
Registration date: 2024-12-26, 1403/10/06
Registration timing: prospective

Last update: 2024-12-26, 1403/10/06
Update count: 0
Registration date
2024-12-26, 1403/10/06
Registrant information
Name
Mohammad javad Biglari
Name of organization / entity
Razi University of Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 3428 2272
Email address
mj.mohammad1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-01, 1403/10/12
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of One Session of Aerobic Exercise and Anodal Stimulation of Dorsolateral Prefrontal Cortex under Hypoxic Condition on Food Craving and Some of its Related Pyschological Factors in Overweight and Obses Men
Public title
Effect of One Session of Aerobic Exercise and Anodal Stimulation of Dorsolateral Prefrontal Cortex on Food cravings in overweight and obese men under hypoxic conditions
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 to 50 years Resident in Kermanshah city center Body mass index (BMI) 25 to 34.9 kg/m2 Have food cravings (score of 108 or higher on the 15-item food craving questionnaire and the 12-item visual analog food craving questionnaire) Obtain a certificate of non-restriction from a physician to participate in an exercise program
Exclusion criteria:
History of seizures, epilepsy or other types of neurological diseases Presence of implantable devices or pacemakers in the body Consumption of cigarettes, alcohol and various drugs Presence of musculoskeletal abnormalities or disorders Participation in weight loss programs in the past 6 months Participation in a regular exercise program in the past 6 months
Age
From 18 years old to 40 years old
Gender
Male
Phase
2
Groups that have been masked
  • Participant
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the order in which subjects will be exposed to 2 different conditions (2 different types of electrical brain stimulation) will be randomized using the Latin square method. For this purpose, first, each subject will be randomly assigned a number between 1 and 20 as an identification code using the website www.random.org. Then, the English letters A and B will be assigned to the two intervention conditions and a Latin square will be created. In this case, a Latin square with two rows and two columns will be created. Finally, participants numbered 1 to 10 will be placed in the first row sequence, and participants numbered 11 to 20 will be placed in the second row sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants are blinded by the principal investigator to the type of brain stimulation they will receive in each session. To do this, in each session, the investigator will hide the tDCS device from the participants' view with a cloth cover after placing the electrodes and starting it.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Razi University of Kermanshah
Street address
Razi University of Kermanshah, University street, Taq Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2024-09-18, 1403/06/28
Ethics committee reference number
IR.RAZI.REC.1403.028

Health conditions studied

1

Description of health condition studied
Overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Obesity in Food craving
Timepoint
Before, immediately, 24 and 48 hours after interventions
Method of measurement
15-item food craving questionnaire and 12-item visual analogue food craving questionnaire

2

Description
Food preference
Timepoint
Before and immediately interventions
Method of measurement
Leeds Food Preference Questionnaire Online Application

3

Description
Appetite level
Timepoint
Before, immediately, 1, 2, 4, 24 and 48 hours after the interventions
Method of measurement
Visual Analogue Subjective Scale of Appetite

Secondary outcomes

1

Description
Impulsiveness
Timepoint
Before and after interventions
Method of measurement
Go/No Go Cognitive Testing Software

2

Description
Risky decision making
Timepoint
Before and after interventions
Method of measurement
Iowa Gambling Cognitive Test Software

3

Description
Cognitive flexibility
Timepoint
Before and after interventions
Method of measurement
20-question cognitive flexibility questionnaire

4

Description
Sense of pleasure
Timepoint
Before applying the interventions and every 3 minutes during aerobic exercise and immediately, 1, 2, 4, 24 and 48 hours after completing aerobic exercise
Method of measurement
11-item emotion scale

5

Description
Arousal level
Timepoint
Before applying the interventions and every 3 minutes during aerobic exercise and immediately, 1, 2, 4, 24 and 48 hours after completing aerobic exercise
Method of measurement
6-point scale of perceived arousal

Intervention groups

1

Description
Intervention group: In this study, all subjects will be exposed to interventional conditions of direct current anodal electrical brain stimulation for 20 minutes and an intensity of 2 mA. For stimulation, a Neurostim stimulator manufactured by Medina Teb Company will be used. Target areas in the brain are identified using the 20-10 international brain mapping system and stimulation of the target areas is performed using two special stimulation electrodes and a special electroencephalogram cap.
Category
Treatment - Devices

2

Description
Control group: Control group: In this study, all subjects will be exposed to a control session including electrical brain stimulation in a sham mode (placebo effect) in addition to the intervention session. All details of the protocol implementation in the control mode will be similar to the intervention mode, with the difference that in the control mode, electrical brain stimulation will not be performed and the electrical current of the stimulating device will be deactivated after 30 seconds. The duration of the control condition will also be 20 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Sport Sciences of Razi University of Kermanshah
Full name of responsible person
Ehsan Amiri
Street address
Faculty of Sport Sciences, Razi University of Kermanshah, Daneshgah Street, Taq Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4585
Email
e.amiri@razi.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Mostafa Mostafaei
Street address
Razi University of Kermanshah, Daneshgah Street, Taq Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4515
Email
b.mostafaei@razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University of Kermanshah
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Ehsan Amiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sport Sciences, Razi University of Kermanshah, Daneshgah Street, Taq Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4585
Email
e.amiri@razi.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Ehsan Amiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sport Sciences, Razi University of Kermanshah, Daneshgah Street, Taq Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4585
Email
e.amiri@razi.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Ehsan Amiri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sport Sciences, Razi University of Kermanshah, Daneshgah Street, Taq Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4585
Email
e.amiri@razi.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data can be shared after subjects are de-identified.
When the data will become available and for how long
6-9 months after results are printed
To whom data/document is available
Supervisor and research student
Under which criteria data/document could be used
Meta-analysis
From where data/document is obtainable
If you need to receive documents, please send an email to Ehsan Amiri, a faculty member at Razi University, at the following email address: e.amiri@razi.ac.ir.
What processes are involved for a request to access data/document
In case of formal request, stating the relevant reasons and providing full details, the data will be sent via email after 72 hours.
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